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QSYMIA Drug Profile
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» See Plans and PricingWhen do Qsymia patents expire, and what generic alternatives are available?
Qsymia is a drug marketed by Vivus and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-four patent family members in nineteen countries.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
US ANDA Litigation and Generic Entry Outlook for Qsymia
There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for QSYMIA
| International Patents: | 64 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 11 |
| Patent Applications: | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for QSYMIA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for QSYMIA |
| DailyMed Link: | QSYMIA at DailyMed |
Recent Clinical Trials for QSYMIA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Minnesota | Phase 2 |
| Woman's | Phase 3 |
| AstraZeneca | Phase 3 |
Pharmacology for QSYMIA
| Drug Class | Sympathomimetic Amine Anorectic |
| Mechanism of Action | Cytochrome P450 3A4 Inducers Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Appetite Suppression Increased Sympathetic Activity Decreased Central Nervous System Disorganized Electrical Activity |
Paragraph IV (Patent) Challenges for QSYMIA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| QSYMIA | CAPSULE, EXTENDED RELEASE;ORAL | phentermine hydrochloride; topiramate | 022580 | 2013-07-18 |
US Patents and Regulatory Information for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for QSYMIA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | Start Trial | Start Trial |
| Vivus | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-001 | Jul 17, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for QSYMIA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Chile | 2010001366 | Start Trial |
| African Regional IP Organization (ARIPO) | 9801429 | Start Trial |
| World Intellectual Property Organization (WIPO) | 9800130 | Start Trial |
| Canada | 2686633 | Start Trial |
| European Patent Office | 2300002 | Start Trial |
| Australia | 732923 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
